Phase 1 Study of CNK-UT Cell Therapy for Patients with Steroid-Resistant or Steroid-Dependent Graft Versus Host Disease

What this Trial Is About

Researchers are evaluating a new treatment using universal T-cells engineered with a chimeric natural killer receptor CNK-UT for patients who have graft-versus-host disease GVHD that is resistant or dependent on steroids. This study is a phase I, open-label, single-arm trial designed to assess the safety, tolerability, and effectiveness of CNK-UT cells in patients who have not responded to standard treatments including ruxolitinib or other second-line medications. The study also aims to understand how these cells behave in the body through pharmacokinetic and pharmacodynamic assessments. The treatment involves two study stages dose escalation and dose expansion. In the dose escalation phase, participants receive a single intravenous infusion of CNK-UT cells at increasing doses to determine the maximum tolerated dose and observe any dose-limiting toxicities over 21 days. If tolerated, participants move to the dose expansion phase where multiple doses of CNK-UT cells are given, with dosing and frequency adjusted based on earlier results. This approach allows researchers to study both safety and potential benefits of repeated dosing. Participants will be closely monitored throughout the study with assessments including adverse event tracking up to one year, response evaluations over six months, and blood tests to measure immune cell levels and drug behavior up to 48 weeks. The primary outcomes focus on safety signals and maximum tolerated dose, while secondary outcomes include measures of treatment response, survival, and drug kinetics. The total study duration includes active treatment periods and long-term follow-up to ensure comprehensive evaluation of the therapys impact.

Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD